SUPPLY CHAIN ARTICLES
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Can America's Retreat On mRNA Be Europe's Opportunity?
With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles
In the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
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Plasmid Production: 3 Key Takeaways For mRNA Manufacturing
Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the past, present, and future of supply chain security, ways the biopharma industry can secure supply chains and minimize risks, and more.
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Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.
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The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.
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Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.